Elocon vs Fluticasone in Localized Psoriasis (P03197)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00763529
First received: September 29, 2008
Last updated: October 14, 2008
Last verified: October 2008
  Purpose

This is an open-label, randomized, parallel-group clinical study. The primary objective is to assess the difference in response rate between mometasone furoate cream 0.1% (once daily) vs fluticasone propionate cream 0.05% (twice daily) by the end of Day 4 and Day 8 in the management of Indian patients with localized psoriasis.


Condition Intervention Phase
Psoriasis
Drug: Mometasone
Drug: Fluticasone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Elocon vs Fluticasone in Localized Psoriasis

Resource links provided by NLM:


Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Reduction in mean symptom scores for erythema, induration, pruritius, and scaling on Day 4. [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
  • Reduction in mean symptom scores for erythema, induration, pruritius, and scaling on Day 8. [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
  • Clinical evaluation of the change in disease status which would be defined as improvement by Day 4 relative to their severity at entry in treated areas. [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
  • Clinical evaluation of the change in disease status which would be defined as improvement by Day 8 relative to their severity at entry in treated areas. [ Time Frame: Day 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 15. [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
  • Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 22. [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 29. [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
  • Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 15. [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
  • Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 22. [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 29. [ Time Frame: Day 29 ] [ Designated as safety issue: No ]

Enrollment: 245
Study Start Date: January 2003
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Mometasone
Mometasone furoate cream 0.1% applied once daily
Other Names:
  • Elocon
  • SCH 32088
Active Comparator: Arm 2 Drug: Fluticasone
Fluticasone propionate cream 0.05% applied twice daily
Other Name: Cutivate

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >=18 years of age
  • Written informed consent
  • Having localized psoriasis (not more than 5-6 patches)
  • Total size of all patches should be below 8" x 8"
  • Each patient should exhibit any of the following 4 signs of dermatoses:

    • erythema
    • palpability
    • scaling
    • itching (pruritus)

Each of the above signs would be grades according to the following scale:

0 = none

  1. = slight
  2. = moderate
  3. = severe The total Disease Severity Score (ie, the sum of the scores for each of the signs) should be at least 6 (indicative of a moderate to severe disease status)

Exclusion Criteria:

  • Pregnancy or lactation
  • Hypersensitivity to any of the components of the test medication
  • Signs of atrophy in the target area
  • Lesions on palms, soles, and scalp
  • Individuals who may require medications that might affect the natural course of the disease
  • Not having used systemic corticosteroids or antimetabolites or any other topical corticosteroid within 2 weeks prior to enrollment in the study
  • Concomitant tuberculosis/viral infection
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00763529     History of Changes
Other Study ID Numbers: P03197
Study First Received: September 29, 2008
Last Updated: October 14, 2008
Health Authority: India: NIL

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Mometasone furoate
Fluticasone
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on April 23, 2014